Back to resultsTo Assess Efficacy of Nutritional Therapy in Secondary Prophylaxis of Hepatic Encephalopathy Versus Lactulose in Patients With Liver Cirrhosis.
Primary Purpose
Liver Cirrhosis
Status
Withdrawn
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Nutrition
Lactulose
Diet
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis
Eligibility Criteria
Inclusion Criteria:
- Liver cirrhosis (Child B or Child C class)
- Age between 18-60 years
- History of recovery from episodeof overt hepatic encephalopathy (West-Haven grade 1 and above) in last 12 months.
Exclusion Criteria:
- Evidence of overt hepatic encephalopathy at the time of enrollment
- History of taking lactulose, rifaximin, neomycin, metronidazole, L-Ornithine L-Aspartate or probiotics in past 7 days
- Alcohol intake during past 6 weeks
- Receiving secondary prophylaxis for spontaneous bacterial peritonitis
- Previous transjugular intrahepatic portosystemic shunts or shunt surgery
- Significant comorbid illness such as heart, respiratory or kidney failure, and neurological disease such as Alzheimer's disease, Parkinson's disease and non hepatic metabolic encephalopathies
- Receiving psychoactive drugs, promotility and hypomotility drugs
- Hepatocellular carcinoma
- Electrolyte abnormality (Serum sodium <125meq/L or serum potassium <2.5meq/L)
- Intercurrent infection such as spontaneous bacterial peritonitis
- Patients of acute on chronic liver failure (ACLF).
Sites / Locations
- Institute of Liver and Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nutrional Therapy Group
Lactulose Group
Arm Description
Nutritional group- Protein of 1.5 gm/kg thrice daily for 6 months
Lactulose - 20 mL thrice daily (maximum) for 6 months
Outcomes
Primary Outcome Measures
Number of patients develop hepatic encephalopathy in both groups
Secondary Outcome Measures
Improvement in health related quality of life over 6 months
Improvement will be defined on the basis of HRQOL (Health Related Quality of Life Index).
Improvement in anthropometry parameters (mid arm circumference, triceps skin fold thickness, hand grip), skeletal muscle mass, body fat mass, percent body fat,BMI over 6 months
Improvement will be measured by dexa scan , C T scan and by measuring mid arm circumference, triceps skin fold thickness, hand grip
Time taken for first breakthrough episode of overt hepatic encephalopathy
Time to first overt hepatic encephalopathy-related hospital admission
Mortality over 6 months
Changes in serum cytokines (IL-1,6,10,18,TNF,Endotoxins,myostatin levels)
Changes in Stool microbiota for 20 patients
Full Information
NCT ID
NCT03161106
First Posted
May 8, 2017
Last Updated
December 8, 2018
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT03161106
Brief Title
To Assess Efficacy of Nutritional Therapy in Secondary Prophylaxis of Hepatic Encephalopathy Versus Lactulose in Patients With Liver Cirrhosis.
Official Title
To Assess Efficacy of Nutritional Therapy in Secondary Prophylaxis of Hepatic Encephalopathy Versus Lactulose in Patients With Liver Cirrhosis- A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Withdrawn
Why Stopped
due lack of funds
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
October 1, 2018 (Anticipated)
Study Completion Date
October 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will be conducted on patients attending /admitted to Department of Hepatology from April 2017 to December 2018 at ILBS, New Delhi .
Clinical, anthropometric and biochemical assessment will be done by candidate, co-supervisors and supervisor. Patients in treatment group will receive nutritional therapy in the form of 30-kcal/kg/day and 1.5gm/kg/day protein with supplements. Other patients will continue diet that they were receiving before along with lactulose. Previous treatment and prophylaxis of variceal bleed any (endoscopic variceal ligation or beta blocker) will be continued as before. All subjects will be followed up every month for treatment compliance and for development of any complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutrional Therapy Group
Arm Type
Experimental
Arm Description
Nutritional group- Protein of 1.5 gm/kg thrice daily for 6 months
Arm Title
Lactulose Group
Arm Type
Active Comparator
Arm Description
Lactulose - 20 mL thrice daily (maximum) for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrition
Intervention Description
Nutrional group-30 kcal/kg with 1.5 grm protein with protein supplements
Intervention Type
Drug
Intervention Name(s)
Lactulose
Intervention Description
Lactulose plus diet consumed by patient
Intervention Type
Dietary Supplement
Intervention Name(s)
Diet
Intervention Description
Protein Powder 15 to 20 gm/meal/day
Primary Outcome Measure Information:
Title
Number of patients develop hepatic encephalopathy in both groups
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Improvement in health related quality of life over 6 months
Description
Improvement will be defined on the basis of HRQOL (Health Related Quality of Life Index).
Time Frame
6 Months
Title
Improvement in anthropometry parameters (mid arm circumference, triceps skin fold thickness, hand grip), skeletal muscle mass, body fat mass, percent body fat,BMI over 6 months
Description
Improvement will be measured by dexa scan , C T scan and by measuring mid arm circumference, triceps skin fold thickness, hand grip
Time Frame
6 Months
Title
Time taken for first breakthrough episode of overt hepatic encephalopathy
Time Frame
6 Months
Title
Time to first overt hepatic encephalopathy-related hospital admission
Time Frame
6 Months
Title
Mortality over 6 months
Time Frame
6 Months
Title
Changes in serum cytokines (IL-1,6,10,18,TNF,Endotoxins,myostatin levels)
Time Frame
6 Months
Title
Changes in Stool microbiota for 20 patients
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Liver cirrhosis (Child B or Child C class)
Age between 18-60 years
History of recovery from episodeof overt hepatic encephalopathy (West-Haven grade 1 and above) in last 12 months.
Exclusion Criteria:
Evidence of overt hepatic encephalopathy at the time of enrollment
History of taking lactulose, rifaximin, neomycin, metronidazole, L-Ornithine L-Aspartate or probiotics in past 7 days
Alcohol intake during past 6 weeks
Receiving secondary prophylaxis for spontaneous bacterial peritonitis
Previous transjugular intrahepatic portosystemic shunts or shunt surgery
Significant comorbid illness such as heart, respiratory or kidney failure, and neurological disease such as Alzheimer's disease, Parkinson's disease and non hepatic metabolic encephalopathies
Receiving psychoactive drugs, promotility and hypomotility drugs
Hepatocellular carcinoma
Electrolyte abnormality (Serum sodium <125meq/L or serum potassium <2.5meq/L)
Intercurrent infection such as spontaneous bacterial peritonitis
Patients of acute on chronic liver failure (ACLF).
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Assess Efficacy of Nutritional Therapy in Secondary Prophylaxis of Hepatic Encephalopathy Versus Lactulose in Patients With Liver Cirrhosis.
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